Mfundo
Khansara pokhala pachiwopsezo cha moyo ndi kusowa kwachipatala kosakwanira, mankhwala ambiri a khansa amavomerezedwa kudzera m'njira yovomerezeka yomwe idayambitsidwa ndi US FDA mu 1992 kutengera zomwe zachitika. Kafukufuku wapeza kuti % yaying'ono yokha ya FDA/EMA idavomereza mankhwala a khansa kuyambira 1992-2017 kudzera mu kuvomerezedwa kofulumira kwa mankhwala omwe adawonetsa phindu lililonse lazachipatala pamafukufuku otsatsa pambuyo pa malonda. Blogyi ikuwonetsa zovuta zakuvomerezeka kwamankhwala a khansa.
United States FDA idayambitsa Accelerated Drug Approval Program mu 1992 kuti pakhale njira yofulumira komanso yowongoka yamankhwala atsopano (kuphatikiza khansa drug) kuti abwere kumsika ndikukwaniritsa zosowa zazachipatala zomwe sizinakwaniritsidwe. Mwachidziwitso, pulogalamuyi ndi yomveka chifukwa makampani opanga mankhwala adzalimbikitsidwa kuti mankhwala awo avomerezedwe mofulumira kudzera mu pulogalamuyi kuti ayambe kupanga ndalama mwamsanga, ndipo odwala omwe akukumana ndi mavuto omwe alibe mankhwala opambana pamsika adzakhala okondwa kuyesa chirichonse chatsopano. . Komabe, chifukwa makampani a pharma sakufunika kuti azichita mayesero akuluakulu komanso atsatanetsatane achipatala omwe amafunidwa pa ndondomeko yovomerezeka ya mankhwala asanayambe kugulitsa mankhwala awo kudzera mu pulogalamuyi, ambiri mwa mankhwalawa apezeka kuti sakuwonetsa phindu lachipatala.
Zakudya Zoti Mudye Mukatha Kuzindikira Khansa!
Palibe khansa ziwiri zomwezi. Pitani kupitilira malangizo omwe anthu onse amapereka kwa onse ndikupanga zisankho zomwe mungakonde pazakudya ndi zowonjezera ndi chidaliro.
Kugwiritsa Ntchito Mapeto a Surrogate Pakuvomerezedwa Kwamankhwala kwa Khansa Yofulumira
Kwenikweni, kuti mankhwala awo avomerezedwe kwakanthawi ndikugulitsidwa kudzera mu pulogalamu yovomerezekayi, mankhwala amawunikidwa ndi zolembera zomwe zimadziwika kuti surrogate endpoints zomwe zimayenera kulosera za phindu lomwe lingachitike. Mapeto a surrogate ndi kufufuza koyezetsa kwa labotale kosavuta (biomarker assay) kapena chizindikiro chakuthupi chomwe sichingakhale chiyeso chachindunji cha momwe wodwalayo akumvera, momwe amagwirira ntchito kapena kupulumuka, komabe amaganiziridwa kuti akhoza kulosera chithandizo chamankhwala kwa wodwalayo. Njirayi ndi yachangu kwambiri kuposa kuyesa mayeso athunthu achipatala chifukwa izi zitha zaka zingapo kuti muwone zotsatira za kupulumuka kwa wodwala komanso momwe moyo wake uliri, ndikusonkhanitsa deta yabwino. Mapeto ovomerezeka omwe amavomerezedwa kuti avomerezedwe ndi mankhwala m'mayesero ofulumizitsa amaphatikizanso kukhudza kwazachipatala komwe ndi puloteni yomwe imalumikizidwa kwambiri ndi matendawa, kapena kuchepetsa kukula kwa chotupa, kuchepetsa kuchuluka kwa maselo ophulika a khansa ya m'magazi, kapena malekezero monga kupulumuka mwaulere ( PFS) ndicho chiwerengero cha masiku, masabata kapena miyezi yomwe matendawa sanapite patsogolo mwa wodwalayo. Mapeto a PFS samalumikizana kwenikweni ndi kupulumuka kwathunthu kwa odwala kapena kusintha kwa moyo wabwino. Kugwiritsira ntchito malekezero ogwirizira pofuna kufulumizitsa kuvomereza kwamankhwala m'matenda oika moyo pachiwopsezo (monga khansa) monga kuyezetsa msanga kuti apeze chipambano chachipatala, kuli ngati kuyesa tayala limodzi kuneneratu za chitetezo chamtsogolo cha magalimoto.
Kafukufuku wopangidwa ndi Harvard School of Medicine adapeza kuti mwa zizindikiro 93 zamankhwala zomwe zidaperekedwa kuvomerezedwa kudzera mu Accelerated Approval Programme ya FDA kuyambira 1992 mpaka 2017, '20% idasintha pakupulumuka kwathunthu, 21% idasintha mwanjira ina. , ndipo 20% anali ndi kusintha kwa njira zomwezo zomwe zimagwiritsidwa ntchito m'mayesero ovomerezeka ndi mayesero ovomerezeka '(Gyawali B et al, JAMA Intern Med. 2019). Izi zikutanthauza kuti mwa mankhwala onse ovomerezeka, mankhwala ochepa kwambiri anali okhoza kusonyeza kupambana kwachipatala m'mayesero otsimikizira. Mayesero otsimikizirika kwenikweni ndi mayesero omwe amagulitsidwa pambuyo pa malonda omwe makampani opanga mankhwala amalamulidwa kuti azichita, kuti alole FDA kuti isankhe ngati ilola kuti mankhwalawa akhalebe pamsika kapena awathetse. Komabe, kachitidweko kamakhala kolakwika kwambiri chifukwa makampani ambiri ogulitsa mankhwala amangogwiritsa ntchito omwewo omwe adavomerezedwa kale kuti ayesetse mayeso awo otsimikizira m'malo mowona mapindu enieni achire monga kupulumuka kwathunthu komanso momwe moyo umakhudzira.
Komanso, zambiri zosonyeza mankhwala ovomerezeka kuchokera ku FDA zimachokera ku malingaliro ochokera kumagulu osiyanasiyana a sayansi monga NCCN, National Comprehensive Cancer Network; ASCO, American Society for Clinical Oncology; ASH American Society for Hematology ndi ena. Mabungwewa amakhazikitsa malangizo azachipatala a gulu la oncology lomwe pambuyo pake limaperekedwa ndi omwe amalipira kuphatikiza Medicare ndi makampani a inshuwaransi wamba. Pakafukufuku wopangidwa ndi ofufuza a ku Oregon Health and Science University kuyerekeza mankhwala omwe amavomerezedwa ndi FDA ndipo akulimbikitsidwa ndi NCCN, ofufuza adapeza kuti "NCCN nthawi zambiri imalimbikitsa kupitilira zomwe FDA idavomereza" komanso kuti "mphamvu ya umboni womwe watchulidwa ndi NCCN yochirikiza malingaliro otere ndiyofooka” (Wagner J et al, BMJ. 2018).
Zomwe zili pamwambazi zikuwonetsa mgwirizano pakati pa makampani akuluakulu azamankhwala omwe akugwiritsa ntchito njira zovomerezeka zofulumizitsa, mabungwe aboma omwe amalipira mtengo wokwera kuti apeze njira zovomerezeka zofulumizitsa izi, komanso magulu azachipatala ndi mabungwe omwe amathandizidwa ndi pharma, omwe nawonso akulimbikitsa. kugwiritsa ntchito mankhwala okwera mtengo komanso oopsa kwa odwala popanda umboni wamphamvu wothandiza pakuwongolera moyo wa odwala kapena kupulumuka kwathunthu. Malinga ndi momwe wodwalayo amaonera, mankhwala atsopano ndi okwera mtengo sangakhale abwinoko nthawi zonse ndipo tiyenera kufunafuna maphunziro ochulukirapo. kusanthula mtengo/phindu mankhwala okwera mtengo omwe amagulitsidwa a khansa.
Chakudya chomwe mumadya komanso chomwe chimakupatsani thanzi ndi chisankho chomwe mumapanga. Lingaliro lanu liyenera kuphatikizapo kulingalira za kusintha kwa majini a khansa, khansa, chithandizo chamankhwala chopitilira muyeso, zovuta zilizonse, zidziwitso za moyo, kulemera, kutalika ndi zizolowezi.
Kukonzekera kwa khansa kuchokera ku addon sikudalira pakusaka kwa intaneti. Zimakusankhirani zomwe mungasankhe malinga ndi sayansi yamayendedwe omwe asayansi athu ndi akatswiri a mapulogalamu. Mosasamala kanthu kuti mumasamala kumvetsetsa zomwe zimayambira zamagulu am'thupi kapena ayi - pakukonzekera zakudya za khansa kumvetsetsa kumafunikira.
Yambirani TSOPANO ndikukonzekera zakudya zanu poyankha mafunso okhudzana ndi khansa, kusintha kwa majini, mankhwala opitilira muyeso ndi zowonjezera, chifuwa chilichonse, zizolowezi, moyo, gulu la zaka komanso jenda.
Zakudya Zawekha za Khansa!
Khansara imasintha ndi nthawi. Sinthani ndikusintha zakudya zanu kutengera zomwe zikuwonetsa khansa, machiritso, moyo, zomwe mumakonda, zomwe zingakusangalatseni ndi zina.
Odwala khansa nthawi zambiri amakhala ndi zovuta zosiyanasiyana chemotherapy mavuto zomwe zimakhudza moyo wawo ndikuyang'ana njira zina zochiritsira khansa. Kutenga chakudya choyenera ndi zowonjezera zowonjezera kutengera zomwe asayansi amalingalira (kupewa kuyerekezera ndi kusankha mwachisawawa) ndiye njira yabwino kwambiri yachilengedwe ya khansa ndi zovuta zina zokhudzana ndi chithandizo.